Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease
1 other identifier
interventional
55
1 country
8
Brief Summary
This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2014
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2013
CompletedFirst Posted
Study publicly available on registry
December 17, 2013
CompletedStudy Start
First participant enrolled
April 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2017
CompletedResults Posted
Study results publicly available
May 15, 2018
CompletedMay 15, 2018
April 1, 2018
3 years
December 12, 2013
April 12, 2018
April 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.
First dose of study drug to up to 24 Weeks
Other Outcomes (1)
Change From Baseline in Corneal Staining Score Using a 6-Point Scale
Baseline (Day 1) to Week 12
Study Arms (9)
Stage 1 Cohort 1
OTHERVehicle administered to study eye and Sham administered to non-study eye on Day 1.
Stage 1 Cohort 2
EXPERIMENTALCyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
Stage 1 Cohort 3
EXPERIMENTALCyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
Stage 1 Cohort 4
EXPERIMENTALCyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
Stage 1 Cohort 5A
EXPERIMENTALCyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
Stage 1 Cohort 6A
EXPERIMENTALCyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
Stage 1 Cohort 6B
EXPERIMENTALCyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
Stage 1 Cohort 6C
EXPERIMENTALCyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
Stage 1 Cohort 6D
EXPERIMENTALCyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
Interventions
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation administered as per protocol
Eligibility Criteria
You may qualify if:
- Moderate to severe dry eye disease in both eyes
- Best-corrected visual acuity (BCVA) of 20/100 or better in each eye
You may not qualify if:
- Use of any cyclosporine preparations within 3 months
- Use of topical medications, other than artificial tears, in the eyes within 1 month
- Use of contact lenses in either eye within 1 month
- Stage 2 only: Participation in Stage 1 of this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (8)
Sall Research Medical Center
Artesia, California, 90701, United States
Lugene Eye Institute
Glendale, California, 91204, United States
Lakeside Vision Center
Irvine, California, 92604, United States
Steve Yoelin MD Medical Asscociates
Newport Beach, California, 92663, United States
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
Vision Institute
Colorado Springs, Colorado, 80907, United States
Johns Hopkins University - Wilmer Eye Institute
Baltimore, Maryland, 21287, United States
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, 53142, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Eleonora Safyan
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2013
First Posted
December 17, 2013
Study Start
April 29, 2014
Primary Completion
April 12, 2017
Study Completion
April 12, 2017
Last Updated
May 15, 2018
Results First Posted
May 15, 2018
Record last verified: 2018-04